U.S. Attorney’s Office Subpoenas Biotech Company Serono Regarding Possible ‘Improper Sale’ of AIDS Wasting Drug

The U.S. attorney's office in Boston has subpoenaed the Rockland, Mass.-based biotechnology company Serono regarding possible black market sale of and improper Medicaid billing for Serostim, a drug used to treat severe weight loss related to AIDS, the Boston Globe reports. Federal and state officials involved in the investigation, which has been ongoing for six months, are looking for evidence of possible "improper sale" of the drug, improper billing of state Medicaid programs and improper financial incentives to get doctors and pharmacists to prescribe the drug, according to law enforcement officials close to the case. Serono spokesperson Carolyn Castel said that the company was cooperating with the subpoena. Maryland, New York and New Jersey, in addition to Massachusetts, are involved in the Serostim investigation. A Serono sales representative in New Jersey who was interviewed by New Jersey state attorney general's office officials six months ago said he was asked if the company offered free trips to doctors who prescribed the drugs. He said that the officials also told him that a test the company used to diagnose AIDS wasting, characterized by weight loss of more than 10% of body weight, was not "legitimate" and should not be performed. The New York state attorney general has subpoenaed pharmacists from Brooklyn, N.Y.-based Echo Drugs, the largest supplier of HIV/AIDS medications in the New York metropolitan area, and asked for "every type of document" regarding Serostim.

Counterfeit Target
In the past years, Serono has experienced "a number of controversies" regarding Serostim. Counterfeiters have targeted Serostim, which builds muscle and is "favored" by body builders, because of the drug's high street value. The New York attorney general last week charged a former employee Montefiore Medical Center in the Bronx with faxing "hundreds" of forged prescriptions for Serostim to out-of-state pharmacies and then selling a month's supply of the drug on the black market for approximately $3,000. The FDA "accelerated" approval of the injectable drug in 1996 only after Serono agreed to cap the drug's cost, which is currently $21,000 for a 12-week course. Doctors prescribe the drug "sparingly" because it is not effective for many AIDS patients. According to Dr. Stephen Boswell, executive director of the Fenway Community Health Center in Boston, no solid data exist showing that the drug improves mortality," and there are limited data showing that the drug "improves quality of life." Approximately 6,000 AIDS patients nationwide take the drug (Kowalczyk, Boston Globe, 5/9).